APO-Irbesartan

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

APO-IRBESARTAN

Irbesartan

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about irbesartan. It does not contain all
the available information. It does not take the place of talking to your doctor or
pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using
this medicine against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What this medicine is used for

Irbesartan is used to treat high blood pressure and kidney disease in type 2 diabetic
patients with high blood pressure. It belongs to a group of medicines known as angiotensin-II
receptor antagonists.

How it works

Ask your doctor if you have any questions about why this medicine has been prescribed
for you.

Your doctor may have prescribed this medicine for another reason.

This medicine is available only with a doctor's prescription.

This medicine is not addictive.

There is not enough information to recommend the use of this medicine in children.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:

irbesartan

any other angiotensin-II receptor antagonists or 'sartans'

any of the ingredients listed at the end of this leaflet

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue, throat or other parts of the body

rash, itching or hives on the skin

Do not take this medicine if you have or have had the following medical conditions:

diabetes or moderate to severe kidney impairment, and you are taking aliskiren

diabetic nephropathy and are on an ACE Inhibitor

Do not take this medicine if you are pregnant.

Irbesartan may affect your developing baby if you take it during pregnancy.

Do not take this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives
or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

kidney problems, kidney transplant or dialysis

heart problems

liver problems

diabetes

high levels of potassium in your blood

recent excessive vomiting or diarrhoea

you are strictly restricting your salt intake

psoriasis

Tell your doctor if you are breastfeeding.

Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you are planning to have surgery, dental treatment or an anaesthetic.

If you have not told your doctor about any of the above, tell them before you start
taking this medicine.

Taking other medicines

Tell your doctor and pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
shop.

Some medicines may interact with irbesartan. These include:

other tablets for high blood pressure

fluid tablets or diuretics

lithium

potassium tablets, potassium containing salt substitutes or other medicines that may
increase potassium

anti-inflammatory medicines (e.g. diclofenac, celecoxib)

Taking a combination of irbesartan with a thiazide diuretic (fluid tablet) and an
anti-inflammatory medicine may damage your kidneys.

If you are taking any of these, you may need a different dose, or you may need to
take different medicines.

Other medicines not listed above may also interact with irbesartan.

How to take this medicine

Follow all directions given to you by your doctor and pharmacist carefully.

They may differ to the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist
for help.

How much to take

Your doctor will tell you how much of this medicine you should take, depending on
your condition and whether you are taking any other medicines.

High blood pressure:

The usual starting dose is 150 mg daily. This can be increased to 300 mg daily on
doctors’ advice.

Kidney disease caused by diabetes and high blood pressure:

The usual starting dose is 300 mg daily.

How to take it

Swallow the tablets whole with a glass of water.

When to take it

Take this medicine at about the same time each day.

Taking it at the same time each day will have the best effect and will also help you
remember when to take it.

It does not matter if you take it with or without food.

How long to take it

Continue taking your medicine for as long as your doctor tells you.

Make sure you have enough to last over weekends and holidays.

If you forget to take it

If it is almost time to take your next dose, skip the missed dose and take your next
dose at the usual time.

Otherwise, take it as soon as you remember and then go back to taking your medicine
as you would normally.

Do not take a double dose to make up for missed doses.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some
hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice or go to Accident and Emergency at your nearest hospital if you
think that you or anyone else may have taken too much of this medicine. Do this even
if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

While you are using this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking irbesartan.

Tell any other doctors, dentists and pharmacists who are treating you that you take
this medicine.

If you become pregnant while taking irbesartan, tell your doctor immediately.

Tell your doctor if you are about to have any blood tests.

Tell your doctor if you are going to have surgery or an anaesthetic or are going into
hospital.

Make sure you drink enough water during exercise and hot weather, especially if you
sweat a lot.

Keep all of your doctor's appointments so that your progress can be checked.

Your doctor may occasionally do tests to make sure the medicine is working and to
prevent side effects.

Things you must not do

Do not give this medicine to anyone else, even if they have the same condition as
you.

Do not take your medicine to treat any other complaint unless your doctor tells you
to.

Do not stop taking your medicine or change the dosage without first checking with
your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects
you.

Side effects

Tell your doctor and pharmacist as soon as possible if you do not feel well while
you are taking irbesartan.

This medicine helps most people with high blood pressure, but it may have unwanted
side effects in a few people. All medicines can have side effects. Sometimes they
are serious, most of the time they are not. You may need medical attention if you
get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any
of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following:

headache

dizziness or light-headedness

unusual tiredness, weakness, fatigue

nausea or vomiting

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

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